Can absolute AMH levels, measured before start of (neo)adjuvant chemotherapy, correctly predict recovery of ovarian function within the first two years following (neo)adjuvant chemotherapy in pre/perimenopausal patients with early breast cancer?
ID
Bron
Verkorte titel
Aandoening
primary hormone receptor positive breast cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
recovery of ovarian function is defined as resumption of menstrual cyclicity (at least more than 1 episode of vaginal bleeding, not caused by vaginal atrophy) and/or levels of estradiol and FSH in the postmenopausal range (according to the local laboratory values; in general >110 pmol/l and <20 pmol/l, respectively), being reconfirmed at least once.
Doel van het onderzoek
Can absolute AMH levels, measured before start of (neo)adjuvant chemotherapy, correctly predict recovery of ovarian function within the first two years following (neo)adjuvant chemotherapy in pre/perimenopausal patients with early breast cancer?
Onderzoeksopzet
nvt
Onderzoeksproduct en/of interventie
no intervention
Publiek
A. Jager
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
Tel 010 704 17 33
a.jager@erasmusmc.nl
Wetenschappelijk
A. Jager
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
Tel 010 704 17 33
a.jager@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Inclusion criteria:
• Primary hormone-sensitive (ER >10% positive and/or PgR >10% positive) breast cancer, independent of Her2- receptor status, curatively locally treated
• Age 46 years
• Indication for (neo-)adjuvant chemotherapy according to the Dutch Guidelines for breast cancer treatment (2012)
• Pre- (regular menstrual cyclicity) and perimenopausal women (amenorrhea duration of less than 12 months) before the start of (neo-) adjuvant chemotherapy
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Exclusion criteria:
• Bilateral oophorectomy
• History of hysterectomy (no information on menstrual cycle possible)
• Evidence of distant metastases
• Use of GnRH agonists within 12 months before the start of (neo-) adjuvant chemotherapy
• Use of hormone-containing intra-uterine device (Mirena®), irrespective of age at breast cancer diagnosis (use of copper-containing devices is allowed)
• Chemotherapy prior to inclusion in the study
• Use of aromatase inhibitors or tamoxifen <6 months before start of (neo-) adjuvant chemotherapy
• History of pelvic radiatiotherapy
• History of treatment with cytotoxic chemotherapy
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5343 |
| NTR-old | NTR5575 |
| Ander register | Erasmus Medical Center : MEC13-156 |